— Study Meets Primary Endpoint —
— Appointment of Barry Hafkin, M.D., as Chief Medical Officer —
HAYWARD, CA, USA and SHANGHAI, China I November 3, 2015 I MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced positive top-line results from its second Phase 2 clinical study of the drug candidate MRX-I. MRX-I is an oral oxazolidinone antibiotic designed to treat drug-resistant bacteria such as MRSA and VRE, while offering a safer and better tolerated oxazolidinone antibiotic therapy.
“We are very pleased that results of MRX-I in the second Phase 2 clinical study performed in USA validate the therapeutic potential of this novel agent,” said Dr. Zhengyu Yuan, president and CEO of MicuRx Pharmaceuticals, lnc. “For over 220 patients treated in US and China with MRX-I to-date, the response rates are consistently high. Importantly, MRX-I has not caused myelosuppression, the key limiting side effect of currently available oxazolidinone drugs.”
The Phase 2 double-blind study conducted at six sites in United States enrolled a total of 120 patients with acute bacterial skin and skin structure infections (ABSSSI), each of whom received 10 days of treatment consisting of twice-daily oral administration of either 800 mg of MRX-I (n=80 subjects) or linezolid (n=40). For the primary efficacy end point, 90% of patients (72/80) in the MRX-I group achieved early clinical response, compared to 87.5% of patients (35/40) in the linezolid group. MRX-I demonstrated a favorable safety and tolerability profile. No drug-related serious adverse events or discontinuation of the treatment due to adverse event were noted in MRX-I patients.
These positive results are in line with those of the first Phase 2 clinical study in complicated skin and soft tissue infections performed by MicuRx in China. As reported in August 2015, the clinical cure rates at the test-of-cure point were comparable for the MRX-I 800 mg group (96.5%) and Zyvox group (95.5%). In that study, among the patients who received more than 10 days of drug therapy, one-third of patients in linezolid group experienced a platelet reduction of at least 30 percent by the end of therapy, with no such myelosuppression detected in 800 mg MRX-I group. Extended use of oxazolidinone antibiotics is known to cause platelet reduction, the key sign of myelosuppression.
Appointment of Barry Hafkin, M.D., as Chief Medical Officer
MicuRx has also announced the appointment of Barry Hafkin, M.D., to the position of the chief medical officer.
“Barry brings the top-notch clinical development skills from both big pharma and small biotech companies, as well the first-hand experience of an infectious diseases physician,” said Dr. Yuan. “He has taken multiple agents successfully through the clinic and onto the market, including the current top oxazolidinone drug Zyvox®. His deep understanding of infectious diseases and the unmatched clinical experience will greatly enhance MicuRx’s ability to advance our antibiotic pipeline.”
Dr. Hafkin brings over 20 years of experience in successful drug development and commercialization. Prior to MicuRx, Dr. Hafkin held key executive roles at Nobelex, Affinium, Cumbre, Advancis, and Boehringer Ingelheim. In addition, he served as senior director and therapeutic area director for infectious diseases at Pharmacia, leading the global development of the blockbuster oxazolidinone drug Zyvox® (linezolid).
About MicuRx Pharmaceuticals, Inc.
MicuRx (http://www.micurx.com) is discovering and developing novel antibiotics to combat infections due to drug-resistant bacteria. Positioned to capture the benefits of United States research and development expertise together with the high quality, cost-efficient discovery, preclinical and development infrastructure in China, the company has built a pipeline of discovery and development programs targeting Gram-positive and Gram-negative pathogens. The company has research and development facilities outside San Francisco, CA in the United States and in Shanghai, China.
SOURCE: MicuRx Pharmaceuticals
Post Views: 150
— Study Meets Primary Endpoint —
— Appointment of Barry Hafkin, M.D., as Chief Medical Officer —
HAYWARD, CA, USA and SHANGHAI, China I November 3, 2015 I MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced positive top-line results from its second Phase 2 clinical study of the drug candidate MRX-I. MRX-I is an oral oxazolidinone antibiotic designed to treat drug-resistant bacteria such as MRSA and VRE, while offering a safer and better tolerated oxazolidinone antibiotic therapy.
“We are very pleased that results of MRX-I in the second Phase 2 clinical study performed in USA validate the therapeutic potential of this novel agent,” said Dr. Zhengyu Yuan, president and CEO of MicuRx Pharmaceuticals, lnc. “For over 220 patients treated in US and China with MRX-I to-date, the response rates are consistently high. Importantly, MRX-I has not caused myelosuppression, the key limiting side effect of currently available oxazolidinone drugs.”
The Phase 2 double-blind study conducted at six sites in United States enrolled a total of 120 patients with acute bacterial skin and skin structure infections (ABSSSI), each of whom received 10 days of treatment consisting of twice-daily oral administration of either 800 mg of MRX-I (n=80 subjects) or linezolid (n=40). For the primary efficacy end point, 90% of patients (72/80) in the MRX-I group achieved early clinical response, compared to 87.5% of patients (35/40) in the linezolid group. MRX-I demonstrated a favorable safety and tolerability profile. No drug-related serious adverse events or discontinuation of the treatment due to adverse event were noted in MRX-I patients.
These positive results are in line with those of the first Phase 2 clinical study in complicated skin and soft tissue infections performed by MicuRx in China. As reported in August 2015, the clinical cure rates at the test-of-cure point were comparable for the MRX-I 800 mg group (96.5%) and Zyvox group (95.5%). In that study, among the patients who received more than 10 days of drug therapy, one-third of patients in linezolid group experienced a platelet reduction of at least 30 percent by the end of therapy, with no such myelosuppression detected in 800 mg MRX-I group. Extended use of oxazolidinone antibiotics is known to cause platelet reduction, the key sign of myelosuppression.
Appointment of Barry Hafkin, M.D., as Chief Medical Officer
MicuRx has also announced the appointment of Barry Hafkin, M.D., to the position of the chief medical officer.
“Barry brings the top-notch clinical development skills from both big pharma and small biotech companies, as well the first-hand experience of an infectious diseases physician,” said Dr. Yuan. “He has taken multiple agents successfully through the clinic and onto the market, including the current top oxazolidinone drug Zyvox®. His deep understanding of infectious diseases and the unmatched clinical experience will greatly enhance MicuRx’s ability to advance our antibiotic pipeline.”
Dr. Hafkin brings over 20 years of experience in successful drug development and commercialization. Prior to MicuRx, Dr. Hafkin held key executive roles at Nobelex, Affinium, Cumbre, Advancis, and Boehringer Ingelheim. In addition, he served as senior director and therapeutic area director for infectious diseases at Pharmacia, leading the global development of the blockbuster oxazolidinone drug Zyvox® (linezolid).
About MicuRx Pharmaceuticals, Inc.
MicuRx (http://www.micurx.com) is discovering and developing novel antibiotics to combat infections due to drug-resistant bacteria. Positioned to capture the benefits of United States research and development expertise together with the high quality, cost-efficient discovery, preclinical and development infrastructure in China, the company has built a pipeline of discovery and development programs targeting Gram-positive and Gram-negative pathogens. The company has research and development facilities outside San Francisco, CA in the United States and in Shanghai, China.
SOURCE: MicuRx Pharmaceuticals
Post Views: 150
